Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

Completed · Not applicable

Conditions studied: Acute Otitis Media, Acute Otitis Externa

In brief

Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.

Key facts

Study ID

NCT02918773

Run by

Emory University

People needed

22

Starts

2016-10-15

Expected to finish

2017-04-15

Last updated by the study team

2018-07-13

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be a pediatric emergency care clinicians providing care at an emergency department a participating children's hospital
• Willing to agree to random assignment to either a smartphone otoscope device or a conventional otoscope device for the 6-month study period
• Willing to log patient encounters that included the an otoscopic examination for non-traumatic indication for each shift
• Willing to document and report episodes of care in which the assigned otoscopic device could not be used on a study-eligible otoscopic examination
• Willing to complete an end of study assessment, if assigned to use the smartphone otoscope

You may not qualify if…

• Declines to give informed consent to participate in the study

Where it is running

• Children's Healthcare of Atlanta at Hughes Spalding — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.